Card Set Information
Prevention of SREs in patients with bone mets from solid tumors
Limitation of use
Not indicated for pts with bone mets from multiple myeloma
Dosage and Admin
120 mg every 4 weeks as SQ injection in upper arm, upper thigh or abdomen
dosage forms and strengths
120 mg/ 1.7 mg/mL single use vial
Warnings and Precautions
Osteonecrosis of the Jaw
Warnings re: Hypocalcemia
Severe Hypocalcemia can occur. Corret hypocalcemia prior to initiating XGEVA. Monitor for Symptoms.
Monitor Ca levels and supplement with Ca and Vit D
Warnings re: ONJ
Perform an oral exam prior to starting XGEVA. Monitor for symptoms; Avoid invasive dental procedures during treatment.
Fatigue/Astenia 45 vs 46
Hypophosphatemia 32 vs 20
Nausea 31 vs 32
Dyspnea 21 vs 18
Most common AEs leading to DC
Hypocalcemia 18 vs 9
ONJ 2.2 vs 1.3
: may cause fetal harm
: May impair mammary gland devt and lactation. d/c drug or nursing
: Safety/effic not estab
: cCl <30 or on dialysis are at risk for hypocalcemia. Suppl w ca or Vit D
Safety was evaluated in ? randomized, ________, double-dummy trials in _________ patients with bone mets from ? cancer, ? cancer, or other solid tumors, or lytic bony lesions from ______.
Median duration XGEVA exposure was __ months
Of pts receiving XGEVA ___% were female, and ____% were white
Exclusions for studies
Hx of ONJ or OMJ
active dental/jaw condition needing surgery
planned invasive dental procedure
Other entry criteria
cCL 30 mL/min or more
Corr Ca 8-11.5 mg/dL
incidence of severe hypocalcemia (less than 7) occurred in ___ of XGEVA patients and ___ of zoledronic acid tx'd patients
( OF THOSE 33% had 2+ episodes, 16% had 3+ episodes)
ONJ in 3 studies was confirmed in ___ of patients with XGEVA and ___ with zoledronic acid.
extended treatment phase of 4 months= 2.2% with XGEVA
What color is XGEVA
clear, colorless to pale yellow
Storage of XGEVA
2-8 degrees C (36-46F) in original carton. Do not freeze. Upon removal from fridge, keep under 77 degrees, do not expose to light, use within 14 days.
Avoid _____ _____ of XGEVA
Advise patients to contact HCP for:
Symptoms of Hypocalcemia
Symptoms of ONJ
Persistent pain or slow healing of mouth
Pregnancy or nursing
Advise pts of need for:
Proper oral hygeine and routine dental care
Informing dentist they take XGEVA
Avoiding dental procedures while taking XGEVA
Also that marketed as PROLIA.
Description: XGEVA is a ____ ____ mab that binds to human ____
pH of XGEVA
RANKL is a ________or soluble _____ essential for ______, _____, and ____ of ______, the cells responsible for bone resorption.
formation, function, and survival
Increased ______ ______, stimulated by RANKL is a mediator of bone _____ in solid tumors with osseous ______.
Possible effects of XGEVA in peds
may impair bone growth in children with open growth plates
may inhibit eruption of dentition
All patients were on concomitant chemo